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Validation of the QUANTA Flash tTG IgA detection system

Femi Saleh and colleagues assess the value of a new chemiluminescence method to detect antibodies to human tissue transglutaminase in coeliac disease.

Coeliac disease is a small bowel enteropathy, triggered by dietary gluten in genetically susceptible individuals. The detection of immunoglobulin (Ig) A antibodies directed against tissue transglutaminase-2 (tTG2) is a standard first-line investigation for the disease.

            QUANTA Flash IgA tTG is a relatively new method for the detection of tTG IgA antibodies, for use with the BIO-FLASH analyser, a highly automated benchtop instrument that is mostly dedicated to autoimmune and infectious disease serology (Fig 1). The method utilises tTG-coated paramagnetic beads, which are incubated with patient serum before washing and magnetisation; bound antibody is then detected by the addition of isoluminol-conjugated anti-human IgA and trigger reagents, producing a luminescence reaction that is detected by the BIO-FLASH optical system. Relative light emitting units (RLUs) are then converted to chemiluminescence units (CU) with reference to a predefined, lot-specific master curve.

            The objectives of this study are to evaluate the diagnostic performance of QUANTA Flash IgA tTG antibody against the existing method (QUANTA Lite R h-tTG IGA ELISA) and to assess the ability of the system to detect potentially IgA-deficient sera.

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